Design qualification is defined as a verification process of design to meet specific requirements related to quality of pharmaceuticals and manufacturing practices. However, design qualification procedures in pharmaceuticals are one of the reasons why some products do not make it onto drugstore shelves.
It is important that these procedures are taken into account and followed closely. The scope of design qualification is intended to include activities that include the design phase, development and design to include equipment procurement and any activities of supplier work. To simplify these processes, we will address them in three important steps.
1. Specification of User Requirements:
At this stage, it is important to look into the requirement specification of the purchase requisition also known as the purchase order. This can be done by a vendor who is supposed to finalize the supply of material that meets the financial and technical specifications.
After checking the PO with the equipment according to your inventory specifications, it is important to check them against the vendor’s standards. It is important to meet each category so that they are a perfect match. Required to see technical specifications, traceability and vendor acceptance for delivery.
2. Verification Process:
This phase is essential as you need to conduct an audit of detailed design features This is mainly due to the tracing process and product drawing. At this stage, deviations must be drafted into a report, and they must be submitted to a vendor and documentation for the company.
3. Final Check:
This stage is critical because it is the last stage where no mistakes are expected. As such, detailed design features focus on the overall outcome of the product. It is based on deviation reports, and is expected to produce a summary of results.
From here on the corrective actions will be conducted in site acceptance testing or in the process of commissioning the product based on the convenience of both buyer and seller.
Design qualification is the primary document that confirms that the design is expected to perform. Meeting the User Requirement Specification (URS) is critical to design qualification as it will allow design validation.
Using a design validation protocol, it is possible to determine whether the item will deliver its full functionality based on the URS. It should also comply with the requirements of the Validation Master Plan These are fundamental processes for any design process in the pharmaceutical industry.